Actively Recruiting

Phase 4
Age: 13Years - 25Years
All Genders
Healthy Volunteers
NCT05898087

Subpectoral Bupivacaine for Pain Management in Adolescent Reduction Mammaplasty

Led by Connecticut Children's Medical Center · Updated on 2025-05-29

128

Participants Needed

2

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The main question this randomized control trial aims to answer is: • Is the use of intraoperative subpectoral bupivacaine associated with decreased post-operative pain in adolescent patients who undergo bilateral reduction mammaplasty Participants will be randomized into the study group that intraoperatively receives 30cc of subpectoral bupivacaine injections or into the control group that intraoperatively receives 30cc of injectable saline subpectorally. All participants will keep a pain log and pain medication log at home for the first week following surgery. Researchers will compare to see if patients who receive subpectoral bupivacaine have lower pain scores in the PACU, and lower use of narcotics post-operatively when compared to the control group who receive injectable saline.

CONDITIONS

Official Title

Subpectoral Bupivacaine for Pain Management in Adolescent Reduction Mammaplasty

Who Can Participate

Age: 13Years - 25Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female
  • Age 13 to 25 years at the time of surgery
  • Undergoing bilateral reduction mammaplasty at Connecticut Children's between 1/1/2022 and 12/31/2025
  • Parent or legal guardian able to understand and willing to sign informed consent
Not Eligible

You will not qualify if you...

  • History of substance use disorder or chronic pain requiring pain specialist management
  • Currently taking narcotics at time of surgery
  • History of liver or kidney dysfunction
  • Known allergy to bupivacaine
  • Pregnancy confirmed by urine test before surgery
  • Non-verbal or developmental delays preventing reliable pain reporting
  • Significant post-operative complications
  • Not meeting the inclusion criteria
  • Lost to follow-up before 1 and 4 week post-operative visits

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Connecticut Children's

Farmington, Connecticut, United States, 06032

Actively Recruiting

2

Connecticut Children's

Hartford, Connecticut, United States, 06106

Actively Recruiting

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Research Team

L

Lauren C Schmidtberg, PA-C

CONTACT

C

Christopher Hughes, MD, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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